Despite criticism from several members of its own advisory committee, and in the midst of a national epidemic of opioid overdoses, the Food and Drug Administration (FDA), in late 2018, approved a new opioid painkiller called Dsuvia.
Originally developed by the Department of Defense (DOD) for use on the battlefield, the tablet is smaller than a single Tic-Tac mint, but five to 10 times stronger than the deadly opioid fentanyl.
Not until 2020, however, did the media learn that the Federal Bureau of Investigation (FBI) issued an intelligence bulletin shortly after the drug’s approval, essentially suggesting that in the wrong hands, this drug will be deadly.
“Because of its potency, Dsuvia will likely cause deaths at a rate surpassing that associated with fentanyl, increasing the overall opioid-related death rate in the near term,” reports Yahoo News, which obtained a copy of the FBI bulletin marked “for official use only.”
What is Dsuvia?
A synthetic opioid analgesic, Dsuvia is a sublingual tablet form of Sufentanil, a narcotic medication 1,000 times stronger than morphine.
Sufentanil is most often used by anesthesiologists as a primary anesthetic agent, but it can also be used to treat acute pain.
In hopes of finding a stronger, longer-acting alternative to the use of injectable morphine for soldiers wounded in combat, the DOD tapped the fledgling pharmaceutical company AcelRx to develop the drug.
The small tablet, placed under the tongue of a critically injured soldier quickly enters the bloodstream and is intended to help manage pain for nearly an hour.
However, critics of this new, incredibly potent opioid believe the only reason the FDA approved the drug was because of pressure from the Department of Defense.
They also point out that so far, the military has not purchased any of the medication and is now using different protocols for managing the pain of wounded soldiers.
Because the FDA approved Dsuvia, though, AcelRx is free to market and sell its new drug to hospitals, surgery centers and to oral surgeons, which has experts worried about this drug getting out on the black market.
What are the Most Common Dsuvia Side Effects?
Though there is a slight decline in the number of fatal drug overdoses in the past year, nearly 70,000 Americans lost their lives in 2018, with an estimated 70 percent of them related opioids like fentanyl.
Like other prescription opioids, Dsuvia is potentially very addictive, though it is only supposed to be approved for one dose at a time and only in medical settings. Physicians cannot write prescriptions for the medication outside of a hospital or surgery usage.
The drug is a central nervous system suppressant and because of Dsuvia’s potency, it can come with very serious side effects.
Typical Dsuvia Side Effects May Include Some of the Following:
- Respiratory depression or even respiratory arrest
- Nausea or vomiting
- Extreme drowsiness
- Mental confusion
- Potential for seizures or a coma if misused
Among the complaints some experts have about the medication, one of the most common is the one-size-fits-all dose of Dsuvia.
There is only one option for dosage, which means health care professionals are not able to adjust for a person’s weight, tolerance, or other important medical factors.
This can potentially endanger patient lives if they are unknowingly sensitive to opioids or are accidentally given more than one dose in a short amount of time.
Pain Management Medication Issues
Even though the Department of Defense invested $22 million into developing Dsuvia and has yet to purchase any of it, AcelRx is slowly making headway in the opioid medication market.
As the coronavirus continues to ravage the U.S. in 2020, many hospitals are facing shortages of other opioid drugs and AcelRx is marketing Dsuvia as an effective opioid for when patients need intubation.
There’s no evidence so far that the medication has made its way to the black market, or that it is being mixed with other drugs at this time, like we’ve seen with fentanyl being mixed with Xanax or Norco on the street.
Proponents of Dsuvia believe there are safeguards to protect that from happening, but others aren’t so sure.
Andrew Kolodny, medical director at the Opioid Policy Research Collaborative at Brandeis University, told Yahoo News, that the protections set forth by the FDA, that the medication only be administered in “medically supervised settings,” is vague.
“[AcelRx] isn’t likely to just sit on their hands and hope that doctors prescribe this new product that they’ve invested millions in,” Kolodny said in the interview. “They will do everything they can to see a return on their investment.”
Opioid Epidemic By the Numbers
Below are two infographics from the U.S. Dept. of Health and Human Services that show heroin and opioid use and deaths from 2016 and 2018.
While the numbers show usage has dropped, overdose deaths have continued to rise, despite efforts to educate the public through the use of media reporting and awareness campaigns designed to inform people of the dangers.
Much of the overdose problem stems from the availability of stronger drugs that are mixed with others to boost the potency on the street.
Fentanyl is one of the biggest threats, but others such as Carfentanil have also shown to be problematic.
These stronger analogues pose a grave danger because many users don’t know what they are ingesting, or that the higher potency poses a risk. In fact, may dealers often do not know exactly what they are selling to others.
There haven’t been any reports about Dsuvia being available on the street or black market yet, so only time will tell if it becomes a similar problem as some of the other high-potency drugs that have caused fatal overdose issues in the United States and around the world.
We can only hope that Dsuvia remains out of the public access and that similar high-strength drugs remain so as well.
Just when the opioid epidemic begins to show signs of retreating, we learn about another potential new drug that may fuel the fire once again.